Evaluation of the Efficacy and Safety of Using Platelet-rich Fibrin (PRF)-Based Lipobolus for the Immediate Reconstruction of Defects After Breast-conserving Resection for Breast Cancer (Minimally Invasive Primary Immediate Grafting)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride).
- Who it may be relevant to
- Registry conditions: Breast Cancer, Lipofilling, Fat Graft, Platelet Rich Plasma. Basic parameters: 18 years — 69 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this clinical trial is to learn if a special type of fat graft, made by mixing a person's own fat with platelet-rich fibrin (PRF), works to fix breast shape defects after cancer surgery. PRF is a substance made from a person's own blood that is rich in growth factors, which may help the graft survive better. The main questions it aims to answer are: What percentage of the fat graft's volume remains in place 3 months after radiation therapy? What is the safety of this procedure, including its side effects and any impact on cancer returning? Participants will: * Undergo standard breast-conserving surgery to remove the tumor * Have liposuction (fat removal) from their own belly or thighs * Receive a "lipobolus" (their own fat mixed with PRF) placed into the breast defect during the same surgery * Follow up for 12 months with ultrasound scans, physical exams, and questionnaires (BREASTQ) about their satisfaction and quality of life
Interventions
- Procedure Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride)
The intervention is a single surgical procedure using a "lipobolus" - a modified fat graft made from the participant's own tissues to restore breast shape after cancer surgery. How it is prepared during surgery: About 200 mL of fat is harvested from the participant's belly using liposuction. Separately, 60 mL of blood is drawn and spun in a centrifuge to obtain platelet-rich plasma (PRP). The fat, PRP, and calcium chloride are mixed. Calcium chloride activates the PRP, forming a thick, gel-lik
Primary outcome measures
- Percentage of Lipobolus Volume Retention at 3 Months Post-Radiotherapy [Time frame: 3 months after completion of radiotherapy]
Secondary outcome measures (4)
- Patient Satisfaction with Aesthetic Results Measured by BREAST-Q [Time frame: Baseline (pre-operatively), 3 months after radiotherapy, 6 months after radiotherapy, 12 months after surgery]
- Frequency of Locoregional Recurrence and Distant Metastasis [Time frame: From the date of surgery through 12 months of follow-up (and continuing throughout the study observation period)]
- Dynamic Changes in Lipobolus Volume Assessed by Ultrasound [Time frame: 7 days after surgery; 1 month after radiotherapy; 3 months after radiotherapy; then every 3 months through 12 months post-surgery (i.e., at 6, 9, and 12 months after surgery)]
- Type and Frequency of Complications [Time frame: Immediately after the procedure (within 30 days post-surgery) and after completion of radiotherapy (through 12 months of follow-up)]
Eligibility criteria
Inclusion criteria
- Histologically verified breast cancer (BC).
- Disease stage from cTis to cT2 according to the TNM classification (AJCC, 8th edition).
- Tumor grade G1 or G2.
- Estrogen receptor positivity (ER+).
- ECOG performance status = 0.
- Primary tumor size up to 2 cm, based solely on preoperative examination data (mammography, ultrasound, MRI).
- Indications for breast-conserving surgery (BCS) with a breast resection extent determined by a multidisciplinary oncology board.
- Submission of an informed voluntary consent (IVC) regarding participation in the study.
- Ability to understand and comply with the requirements of the study protocol.
Exclusion criteria
- Male gender.
- ECOG ≥ 1.
- Multifocal or multicentric tumor.
- Grade G3.
- Triple-negative or HER2-positive tumor with uncontrolled disease.
- Stage cT3 or higher or distant metastases (M1).
- Inflammatory breast cancer.
- Prior neoadjuvant chemotherapy or hormonal therapy.
- Prior radiation therapy to the breast.
- Presence of blood coagulation disorders (coagulopathy, thrombocytopathy, thrombocytopenia < 100 × 10⁹/L).
- Taking anticoagulants or antiplatelet agents that cannot be temporarily discontinued.
- Presence of active infectious diseases.
- Acute autoimmune diseases.
- Decompensated comorbidities (diabetes mellitus, cardiovascular diseases, etc.).
- Body mass index (BMI) < 18.5 kg/m² (insufficient adipose tissue volume for liposuction).
- Pregnancy or lactation.
- Mental illnesses that prevent informed consent.
- Known allergy to local anesthetics or sodium citrate.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Leningrad Regional Clinical Hospital — Saint Petersburg
Identifiers
NCT: NCT07658170 · 11 · 112025